Background: Sepsis, meningitis and pneumonia annually kill 1.1 million neonates in developing countries; most deaths occur at home.
Objectives: To develop simple clinical criteria, enabling health workers in communities to identify neonates with potentially fatal sepsis; and to identify the danger signs alerting mothers to seek care.
Methods: In a field trial in 39 villages in Gadchiroli, India, trained health workers visited all neonates at home 8 times during the first 28 days of life, recording signs and outcome without interventions during 1995-1996 and with home-based management of sick neonates during 1996-1999. An independent neonatologist assigned the cause of death. We use the term "sepsis" to include sepsis, meningitis and pneumonia. We evaluated 31 signs as predictors of 43 sepsis deaths among 3567 neonates. We also evaluated mothers' observations as the danger signs to seek care.
Results: Simultaneous presence of any 2 of 7 signs (reduced or stopped sucking; weak or no cry; limbs becoming limp; vomiting or abdominal distension; baby cold to touch; severe chest indrawing; umbilical infection) predicted sepsis death with sensitivity 100%, specificity 92%, positive predictive value 27.2% and negative predictive value 100% in the nonintervention period. The criteria identified 10.6% of the neonates in the community as suspected sepsis, at a mean of 5.4 days before death. The criteria remained valid in the postintervention period. Any 1 of the 5 maternally observed danger signs (reduced sucking, drowsy or unconscious, baby cold to touch, fast breathing and chest indrawing) gave 100% sensitivity and identified 23.9% neonates for seeking care.
Conclusion: These criteria identify neonates in the community who are at risk for dying of infection with excellent sensitivity, specificity and negative predictive value but a moderate positive predictive value. They can be used by health workers to select sick neonates for treatment or referral. One potentially fatal case would be treated per 4 presumptive cases treated.